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The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
For the third time in four months, a federal judge has delayed drugmaker Amarin’s lawsuit against the FDA as the two sides try to negotiate a settlement. Read More
Turing Pharmaceuticals CEO Martin Shkreli has been indicted on seven counts of securities and wire fraud for alleged conduct at several of his previous companies. Read More
Drugmakers that have not started complying with worldwide track and trace regulations are behind the eight ball, as most companies only allow for two to three years for implementation, a supply chain expert warns. Read More
The FDA is eliminating the risk evaluation and mitigation strategy for rosiglitazone-containing diabetes drugs, deciding enough is understood about its side effects. Read More